BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 3130117 · Received May 24, 2013

    Report

    Report Number
    2084725-2013-00220
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO GROWTH OF POSITIVE CONTROL BI.

    Additional Manufacturer Narrative · 1

    LOAD NOT RECALLED. MANUFACTURER DATE: 01/03/2013. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, TRENDING BY PRODUCT LINE AND LOT NUMBER, FAILURE MODE AND EFFECTS ANALYSIS. HEALTH HAZARD EVALUATION, AND SYSTEM HAZARD US AND MISUSE ANALYSIS. THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED AND DEMONSTRATED NO ANOMALIES THAT WOULD CONTRIBUTE TO THIS ISSUE. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''NO GROWTH OF BI CONTROL' WAS REVIEWED FROM (B)(4) 2013 THROUGH (B)(4) 2013. THERE IS NO SIGNIFICANT TREND OBSERVED. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''LOAD NOT RECALLED' WAS REVIEWED FROM (B)(4) 2013 THROUGH (B)(4) 2013. THE RISK IS CATEGORIZED INTO "AS LOW AS REASONABLY PRACTICABLE." TRENDING ANALYSIS BY LOT NUMBER WAS NOT PERFORMED. A LOT HISTORY REVIEW IS NOT REQUIRED SINCE THE ASSIGNABLE CAUSE IS USER-RELATED AND IS NOT DUE TO PRODUCT MALFUNCTION. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR THE RISK OF USING INSTRUMENTS FROM A LOAD WITH A POSITIVE BI RESULT. THE RISK IS CONSIDERED LOW PER THE MEDICAL REVIEW. THE SHUMA WAS REVIEWED FOR SIMILAR USER-RELATED ISSUES AND INDICATES THAT THE RESIDUAL RISK IS CONSIDERED "AS LOW AS REASONABLY PRACTICABLE." THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THE CI DISC WAS RED AND THE CAP WAS COMPLETELY DEPRESSED. A SINGLE SPORE DISC AND SINGLE TYVEK® LINER WAS PRESENT. THE OUTER VIAL DID HAVE STRESS MARKS FROM (ATTEMPTED) MANUAL CRUSHING; HOWEVER, THE INNER AMPOULE WAS INTACT. THE INNER AMPOULE CONTAINED DEEP PURPLE MEDIA FLUID CONSISTENT WITH AN UNCRUSHED AMPOULE. THE BI WAS ABLE TO BE SUCCESSFULLY CRUSHED USING THE SUPPLIED TUBE CRUSHER. THEREFORE, THERE IS NO PROBLEM WITH THE PRODUCT THAT WOULD PREVENT ITS SUCCESSFUL CRUSHING. THIRTEEN RETAINS BIS WERE SUBMITTED FOR FUNCTIONAL EVALUATION. THE BI'S WERE CRUSHED AND INCUBATED PER IFU AND MET FUNCTIONAL SPECIFICATION. THE ASSIGNABLE CAUSE FOR THE CODE 'NO GROWTH OF BI CONTROL' IS ATTRIBUTED TO USER ERROR. THE CUSTOMER DID NOT COMPLETELY CRUSH THE POSITIVE CONTROL BI. PER THE IFU "USING ONLY THE SUPPLIED TUBE CRUSHER, SQUEEZE THE STERRAD CYCLESURE 24 VIAL UNTIL THE MEDIA AMPOULE HAS BEEN CRUSHED." HOWEVER, THE CUSTOMER DID NOT CRUSH THE MEDIA AMPOULE. REVIEW OF TRACKING AND TRENDING DATA DID NOT IDENTIFY A TREND THAT REQUIRES FURTHER INVESTIGATION. FURTHER INVESTIGATION INTO ROOT CAUSE OF THE PHYSICAL DAMAGE WILL NOT BE PERFORMED. THE PRODUCT IFU STATES THAT THE CYCLESURE® 24 BI IS INTENDED TO BE USED AS A STANDARD METHOD FOR FREQUENT MONITORING OF THE STERRAD® STERILIZER CYCLES. THE PRODUCT MALFUNCTION CODE OF 'LOAD NOT RECALLED' WAS ADDED BECAUSE THE CUSTOMER DID NOT SUCCESSFULLY RECALL THE LOAD. THIS CODE IS NOT RELATED TO A FUNCTIONAL FAILURE OF THE PRODUCT. FURTHER INVESTIGATION INTO THIS ISSUE IS NOT REQUIRED SINCE EACH CUSTOMER SETS POLICY REGARDING LOAD RELEASE. A CUSTOMER LETTER WAS SENT EXPLAINING THE ROLE OF A POSITIVE CONTROL BI, AS WELL AS ITERATING THAT THE MEDIA AMPOULE MUST BE COMPLETELY CRUSHED. ADDITIONALLY, THE CUSTOMER WAS ADVISED TO FOLLOW THE CURRENT FACILITY POLICY AND PROCEDURES REGARDING RETRIEVAL OF UNUSED INSTRUMENTS AND NOTIFICATION OF THE PHYSICIAN(S), AND TO THEREAFTER REPEAT THE TEST WITH A SECOND STERRAD® CYCLESURE® 24.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED NO GROWTH ON A CONTROL CYCLESURE 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED CYCLE IN THEIR STERRAD STERILIZER. THE LOAD WAS NOT RECALLED SUCCESSFULLY AND THE LOAD CONTENT(S) WERE USED ON PATIENTS. THE LOAD CONTAINED THREE COOPER SURGICAL INSTRUMENTS AND THREE OPHTHALMOLOGY MICROSCOPES. THERE ARE NO REPORTS OF INJURY OR HARM FROM THE EVENT. THE PROCESSED CYCLESURE 24 BIOLOGICAL INDICATOR (BI) RESULTS WERE NEGATIVE. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THIS EVENT IS BEING REPORTED TO THE FDA FOR THE USER ERROR OF RELEASING A LOAD WHEN THE POSITIVE CONTROL BI DID NOT GROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232555 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1